DETAILED ACTION
This Action is in response to the communication filed on 12/12/2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-5, 7-13, 15-18, 20-29, 31-32 are pending.
Claims 4-5, 12-13, 15-16, 18, 22-23, 28-29, 31-32 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/09/2025.
Claims 1-3, 7-11, 17, 19-21, 24-27, 30 are under consideration.
Status of the Rejections/Objections
The cancellation of claims 6, 19, 30 obviates the objection/rejection(s) to these claims.
The amendment to claims 1, 17, 24, obviates the rejections under 35 USC 102 and 35 USC 103 to these claims as well as claims that depend on these claims.
The terminal disclaimer filed on 12/23/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,473,088 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the non-statutory double patenting rejection has been withdrawn. However, upon consideration of the amended claims, it was determined that a statutory double patenting rejection was appropriate for some claims as indicated herein. It is noted that the new statutory double patenting rejection is necessitated by the amendment to the claims.
New Statutory Double Patenting Rejection
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 8 of prior U.S. Patent No. 11,473,088 (of record). This is a statutory double patenting rejection.
Instant claim 1 is drawn to a method of treating cancer in a subject, wherein the cancer includes cells expressing at least one growth hormone receptor, the method comprising: controlling an action of a growth hormone receptor on at least one cancer cell expressing the growth hormone receptor, wherein the controlling an action of the growth hormone receptor includes knock down of the growth hormone receptor via an antibody specific to the growth hormone receptor; and administering a sub-EC50 dose of an anti-tumor drug, wherein the anti-tumor drug is a substrate of an ABC transporter.
Claim 8 of the ‘088 patent is drawn to the method of claim 5 wherein the knock down of the growth hormone receptor is caused by an antibody specific to the growth hormone receptor. Incorporating claims 1 and 5 into claim 8 of the issued patent, claim 8 is drawn to a method of treating cancer in a subject, wherein the cancer includes cells expressing at least one growth hormone receptor, the method comprising: controlling an action of a growth hormone receptor on at least one cancer cell expressing the growth hormone receptor by administering an antagonist of the growth hormone receptor; and administering a sub-EC50 dose of at least one anti-tumor drug, wherein the anti-tumor drug is a substrate of an ABC transporter (claim 1), wherein the controlling an action of the growth hormone receptor includes knock down of the growth hormone receptor (claim 5), wherein the knock down of the growth hormone receptor is caused by an antibody specific to the growth hormone receptor (claim 8).
Accordingly, instant claim 1 is essentially the same scope as claim 8 of the issued patent and a statutory double patenting rejection is appropriate.
Allowable Subject Matter
Claims 7-11, 17, 20-21, 24-27, 30 are allowed.
Claims 2-3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
As indicated above, the cancellation of claims 6, 19, 30 obviates the objection/rejection(s) to these claims.
The amendment to claims 1, 17, 24, obviates the rejections under 35 USC 102 and 35 USC 103 to these claims as well as claims that depend on these claims.
The terminal disclaimer filed on 12/23/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,473,088 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the non-statutory double patenting rejection has been withdrawn. However, upon consideration of the amended claims, it was determined that a statutory double patenting rejection was appropriate for some claims as indicated herein. It is noted that the new statutory double patenting rejection is necessitated by the amendment to the claims. Applicant’s response does not address the new statutory double patenting rejection.
It is noted that the instant application contains claims 4-5, 12-13, 15-16, 18, 22-23, 28-29, 31-32 currently withdrawn from further consideration. Applicant is asked to consider cancelling the withdrawn claims in response to this action in order to expedite allowance of the application as it does not appear that all of the withdrawn claims would be allowable should they become eligible for rejoinder.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637